Device recall
Z-1315-06: Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched…
FDA device recall · Class II · Applied Biotech Inc
Key facts
| Recall number (Z-number) | Z-1315-06 |
|---|---|
| Recall event | 35656 |
| Product | Medplus ER Drug Screen Test Model #5800KAB packaged as 25 individually pouched devices in a labeled kit box. |
| Product code | LCM |
| Recalling firm | Applied Biotech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2012 |
| 510(k) numbers | K003160 |
| FEI number | 1000125390 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database